Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer
A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
1 other identifier
interventional
N/A
1 country
12
Brief Summary
The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy fractions for 5 weeks.
Trial Health
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12 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2003
CompletedFirst Posted
Study publicly available on registry
January 13, 2003
CompletedMay 12, 2011
May 1, 2011
January 10, 2003
May 11, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- years for age;
- Patients with biopsy proven locally advanced adenocarcinoma or squamous cell carcinoma of the esophagus, stage II, III, who have not received previous treatment and are considered to have resectable carcinoma;
- Informed consent;
- Karnofsky performance status ≥ 70%;
- Life expectancy greater than 6 months.
You may not qualify if:
- Diagnosis of lymphoma of the esophagus;
- History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized early stage prostate cancer with patients continuously disease-free;
- Previous chemotherapy or radiation for esophageal cancer or previous radiation therapy to the target field;
- T4 disease, metastatic (stage IV) disease or confirmed invasion of the bronchial tree;
- Extension beyond 2 cm into stomach;
- Liver enzymes \>2.0 x ULN (ALT, AST, bilirubin, alkaline phosphatase);
- Coagulopathy (INR \>1.5, PTT ratio \>1.5);
- Renal insufficiency (creatinine \>2.0 mg/dL; calculated creatinine clearance \<50 ml/min);
- Significant anemia (hematocrit \<28% or hemoglobin \<9 g/dL) (may have RBC transfusion), or thrombocytopenia (platelet count \<100,000/μL)l or leukopenia (WBC \<3,000/µL; ANC \<1,500 μL);
- Contraindication to endoscopic or EUS-guided delivery including obstructive lesions that can not be dilated to pass endoscope;
- Clinical evidence of active infection of any type, including hepatitis B or C virus;
- Due to the embryotoxic effects of chemotherapy, pregnant or lactating women, or men unable or unwilling to practice contraception are excluded;
- Experimental medications within the last four weeks prior to Day 1;
- Chronic systemic corticosteriod use (orally or parenterally administered);
- Significant concurrent medical or psychiatric illness as defined by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GenVeclead
Study Sites (12)
UCSD Cancer Center
La Jolla, California, 92093-0064, United States
University of California, Irvine
Orange, California, 92868, United States
Palo Alto VA Health Care Systems
Palo Alto, California, 94304, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637-1470, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21231-2410, United States
St. Louis University
St Louis, Missouri, 63110, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
US Oncology, Mary Crowley Center
Dallas, Texas, 75246, United States
University of Texas/MD Anderson
Houston, Texas, 77030-4009, United States
Scott & White Center for Cancer Prevention and Care
Temple, Texas, 76508, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Medical College of Virginia
Richmond, Virginia, 23298-0058, United States
Related Publications (1)
Chang KJ, Reid T, Senzer N, Swisher S, Pinto H, Hanna N, Chak A, Soetikno R. Phase I evaluation of TNFerade biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer. Gastrointest Endosc. 2012 Jun;75(6):1139-46.e2. doi: 10.1016/j.gie.2012.01.042. Epub 2012 Apr 18.
PMID: 22520270DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2003
First Posted
January 13, 2003
Last Updated
May 12, 2011
Record last verified: 2011-05